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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of September 24, 2026 No. 1231

About approval of features of import to the Russian Federation and addresses in the Russian Federation the registered original orphan medicines and (or) high-technology medicines for medical application within 12 months after date of their registration in the Russian Federation in the packagings intended for the address in foreign states

The government of the Russian Federation decides:

1. Approve the enclosed features of import to the Russian Federation and addresses in the Russian Federation of the registered original orphan medicines and (or) high-technology medicines for medical application within 12 months after date of their registration in the Russian Federation in the packagings intended for the address in foreign states.

2. This resolution becomes effective after 10 days from the date of its official publication and is effective within 6 years.

Russian Prime Minister

M. Mishustin

Approved by the Order of the Government of the Russian Federation of September 24, 2026 No. 1231

Features of import to the Russian Federation and addresses in the Russian Federation the registered original orphan medicines and (or) high-technology medicines for medical application within 12 months after date of their registration in the Russian Federation in the packagings intended for the address in foreign states

1. Import to the Russian Federation and the address in the Russian Federation of the registered original orphan medicines and (or) high-technology medicines for medical application (further - medicines) within 12 months after date of their registration in the Russian Federation in the packagings intended for the address in foreign states are allowed on condition of compliance of the imported medicines to the requirements established in case of their registration, except for requirements to primary package, secondary (consumer) package, and in the presence on secondary (consumer) package of the medicines which are in circulation, the self-adhesive label containing information on medicine in Russian.

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